Alzheimer DiseasePhase 2NCT05728736
Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
A Phase 2 study testing Lemborexant 25 mg in people with Alzheimer Disease, run by Brendan Lucey at 1 site in United States.
Trial summary
This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lemborexant 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 4 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-80 years
- Any sex
- Any race/ethnicity
- Mini-Mental Status Examination score (MMSE) ≥ 27
- Positive plasma amyloid-beta test (i.e., amyloid-positive)
- Pittsburgh Sleep Quality Index >5
Who cannot join
- Cognitive impairment as determined by history of MMSE < 27
- Inability to speak or understand English
- Any sleep disorders other than insomnia
- No history of moderate-to-severe sleep-disordered breathing and STOP-Bang score > 5
- History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
- No more than mild sleep apnea (AHI <16) on PSG
Show all 27Show fewer
- Sleep schedule outside the range of bedtime 22:00-midnight
- Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
- Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
- Stroke
- Hepatic or renal impairment
- Pulmonary disease (PI discretion)
- Type 1 diabetes
- HIV or AIDS
- Neurologic or psychiatric disorder requiring medication (PI discretion)
- Suicidal ideations
- Alcohol, tobacco or marijuana use (PI discretion)
- Use of sedating medications (PI discretion)
- Inability to get out of bed independently
- In the opinion of the investigator, the participant should be excluded due to an abnormal physical examination.
- Current pregnancy
- Body Mass Index >35
- History of migraines (PI discretion)
- History of drug abuse in the last 6 months
- History or presence of any clinically significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI participant is not a good candidate.
- Urinary or fecal incontinence
- Concurrently enrolled in another trial of an investigational drug or device
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers
Read the detailed description
This study will determine the acute effect of lemborexant on CNS tau phosphorylation and other Alzheimer's disease biomarkers in individuals with poor sleep quality.
- Conditions
- Alzheimer Disease
- Being tested
- Lemborexant 25 mg, Placebo
- Keywords
- poor sleep
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 25 mgDrug
Also called Dayvigo
Lemborexant 25mg will be taken nightly for two consecutive nights.
PlaceboDrug
Also called inactive pill, sugar pil
Placebo will be taken nightly for two consecutive nights
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | 20 participants will be randomized to take lemborexant 25mg at h.s for two consecutive nights Receives: Drug: Lemborexant 25 mg |
| placebo | Placebo comparator | 10 participants will be randomized to take placebo at h.s. for two consecutive nights. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CNS tau phosphorylation
Changes in CSF pT181/T181 ratio compared to placebo
Measured: 48 hours
Secondary outcomes (1)
Changes in other CSF AD biomarkers
Changes in CSF pS202/S202, pT217/T217, and amyloid-beta
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Mar 2023
- Primary completion27 Sep 2023
- Study completion4 Oct 2023
Why it stopped: Study was terminated due to enrollment difficulties and the inability to obtain necessary study supplies. Five participants signed consent; however, no one was randomized. The study was officially terminated with the funding source on 10/04/2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brendan Lucey
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor-investigator, Brendan Lucey, Washington University School of Medicine
- Investigators
- Brendan Lucey, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728736
- Sponsor's protocol ID
- HRPO 202210049
- Status last verified
- Nov 2023
- First submitted
- 5 Feb 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
- ClinicalTrials.gov ID
- NCT05728736
- Acronym / sponsor ID
- HRPO 202210049
- Conditions
- Alzheimer Disease
- Keywords
- poor sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was terminated due to enrollment difficulties and the inability to obtain necessary study supplies. Five participants signed consent; however, no one was randomized. The study was officially terminated with the funding source on 10/04/2023.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brendan LuceyUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers
Detailed description
This study will determine the acute effect of lemborexant on CNS tau phosphorylation and other Alzheimer's disease biomarkers in individuals with poor sleep quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Lemborexant 25 mg20 participants will be randomized to take lemborexant 25mg at h.s for two consecutive nights |
| placebo | Placebo comparator | Drug: Placebo10 participants will be randomized to take placebo at h.s. for two consecutive nights. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60-80 years
- Any sex
- Any race/ethnicity
- Mini-Mental Status Examination score (MMSE) ≥ 27
- Positive plasma amyloid-beta test (i.e., amyloid-positive)
Key exclusion criteria (27 listed)
- Cognitive impairment as determined by history of MMSE < 27
- Inability to speak or understand English
- Any sleep disorders other than insomnia
- No history of moderate-to-severe sleep-disordered breathing and STOP-Bang score > 5
- History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 25 mgAlso: DayvigoLemborexant 25mg will be taken nightly for two consecutive nights. | Drug | treatment |
| PlaceboAlso: inactive pill, sugar pilPlacebo will be taken nightly for two consecutive nights | Drug | placebo |
Primary outcome
Change in CNS tau phosphorylation
Time frame: 48 hours
Changes in CSF pT181/T181 ratio compared to placebo
1 secondary outcome
Changes in other CSF AD biomarkers
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Lucey, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant 25 mg in people with Alzheimer Disease, run by Brendan Lucey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CNS tau phosphorylation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.